drugset
drugset / Trial / NCT05707832

A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus

NCT05707832 ↗

Phase 3 Completed 31 enrolled CSPC Ouyi Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a multi-center, open-label, non-controlled, single-arm clinical trial to evaluate the safety, efficacy and population pharmacokinetics of Amphotericin B cholesteryl Sulfate Complex for Injection domestic formulations (ABCD) in the treatment of confirmed invasive candidiasis (IC) and confirmed/clinically diagnosed invasive aspergillus (IA) disease.

Timeline

Start
2023-03-30
Primary completion
2024-07-30
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 3 mg/kg Intravenous
Subject Amphotericin B Unknown 4 mg/kg Intravenous

Indications

candidiasis, invasive invasive aspergillosis